Evaluation of the effect of folic acid on liver fibrosis and liver function in patients with nonalcoholic fatty liver grade 2 and 3
Design
A randomized controlled clinical trial with parallel design. Total sample size will be 60 and randomization will be done based on the sequences of the random blocks using statistical software.
Settings and conduct
Patients with fatty liver disease will be evaluated for the study inclusion criteria at the gastroenterology clinic of Qom University of Medical Sciences. Liver sonography, fibroscan and biochemical tests measured at baseline and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are diagnosed to have non alcoholic fatty liver disease confirmed with ultrasonography and fibroscan results; Ages between 18-65 years; Serum alanine transaminase enzyme level higher than 30 U/L Exclusion criteria: Pregnancy; Lactation; Alcohol consumption; Having diseases such as hereditary hemochromatosis and Wilson's disease; History of receiving total parenteral nutrition during last 6 months; Consumption of statins and hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine; Intake of folate, B12, vitamin E and omega-3 supplements during the last 6 months
Intervention groups
The intervention group will receive one tablet contains 5 mg folic acid daily for 24 weeks. The control group will receive one tablet of placebo daily for 24 weeks.
Main outcome variables
A change in the grade of liver fibrosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150819023685N2
Registration date:2020-02-22, 1398/12/03
Registration timing:prospective
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Samira Khani
Name of organization / entity
Qom University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 25 3783 2370
Email address
skhani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of folic acid in the treatment of non-alcoholic fatty liver in patients with hepatic fibrosis
Public title
Efficacy of folic acid in the treatment of non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed to have non alcoholic fatty liver disease (grade 2 and 3) confirmed with ultrasonography and fibroscan results.
Ages between 18-65 years
Serum alanine transaminase enzyme level higher than 30 U/L
Exclusion criteria:
Having diseases such as liver disease and decompensated Cirrhosis
Having diseases such as hereditary hemochromatosis and Wilson's disease
Consumption of statins and hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone and chloroquine
Intake of folate, B12, vitamin E and omega-3 supplements during the last 6 months
History of receiving total parenteral nutrition during last 6 months
Pregnancy
Lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to the intervention or control group in the random blocks based on the random number table. The sequence of permuted blocks will be generated with a random number table. An individual with no clinical involvement in the trial, puts the lable of intervention or control group in an opaque and sealed envelope based on the random sequence. Then the other person, who is not aware of random sequences and the envelope content, will assign the patients to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, participants, clinical caregiver, principal investigator, data analyzer and outcome evaluator will be blinded to the allocation to study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No. 83, 4th alley, 1.1 alley, Safashahr Blvd
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.MUQ.REC.1398.148
Health conditions studied
1
Description of health condition studied
Nonalcoholic steatohepatitis
ICD-10 code
K75.81
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver stiffness
Timepoint
At baseline and 24 weeks after the start of the intervention
Method of measurement
Fibroscan
Secondary outcomes
1
Description
Blood levels of liver enzymes
Timepoint
At baseline and 24 weeks after the start of the intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Folic acid tablet, 5 mg, oral, once a day, for 6 months
Category
Treatment - Drugs
2
Description
Control group: placebo tablet, oral, once a day, for 6months
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ahmad Hormati
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
0098 256122053
Email
Hormatia@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Samira Khani
Position
Pharmacology Ph.D., assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of medicine,Pardis Campus, Ghadir Blvd
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3320 9071
Email
pharma_75@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Samira Khani
Position
Pharmacology Ph.D., assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of medicine,Pardis Campus, Ghadir Blvd
City
qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3320 9071
Email
pharma_75@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
A portion of the data regarding demographics variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared.
When the data will become available and for how long
The start of the data access period will be one year after the publication of the results.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
In order to conduct meta analysis studies
From where data/document is obtainable
Samira Khani, Pharmacology Department, School of Medicine, Qom University of Medical Sciences, Ghadir Blvd., Qom, Iran Postal Code: 3736175513 E-mail: pharma_75@yahoo.com Tel: 00982533209071
What processes are involved for a request to access data/document
An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request.